Ranitidine Medications, Including Zantac®, Investigated by FDA

Ranitidine in Heartburn medication

Guest Author: Phil Koerner, PhD. The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have recently announced that they are conducting investigations into certain ranitidine drug products used to Continue Reading

How Nitrosamine Impurities Affect Your Blood Pressure Medicine

How nitrosamine affects blood pressure medicine

Guest Author: Phil Koerner, PhD. The U.S. Food and Drug Administration (USFDA) and The European Medicines Agency (EMA) have set legally-binding limits for nitrosamine impurities in sartan blood pressure medicines. Continue Reading

Powerful Analytical Solutions for Biotherapeutics Development and QC

A look into biotherapeutics development and QC testing in the pharmaceutical industry.

A transformation in the pharmaceutical industry has occurred in the past few decades due to the advancement of biologics as therapeutic agents. What is less often discussed is a similar Continue Reading

LC-MS/MS Method for Determination of NDMA and NDEA in Valsartan

Valsartan

By: Philip J. Koerner, Ph.D. – Global Industry Manager – Pharmaceutical The Korea Food and Drug Administration (KFDA), in cooperation with SCIEX Korea, has recently published an official LC-MS/MS method using Continue Reading